Natural Products Insider

MAR-APR 2019

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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naturalproductsinsider . com 43 "relatively small price premiums in comparison to the expense and burden of litigation" —were "clearly superior to the alternative of forcing consumers to litigate on principle." The court concluded "class members' interests" would best be served by a joint action, and class action litigation was the superior method of resolving the plaintiffs' claims. Ninth Circuit Awards Judgment to Defendants in Vitamin E Case A federal district court in California rejected a consumer's false advertising claims against manufacturers of vitamin E supplements that claimed, on their labels, to "support cardiovascular health" and to "promote immune function" "immune health" "heart health" and "circulatory health" (Dachauer v. NBTY Inc., 2019 U.S. App. LEXIS 887 [9th Cir. Jan. 10, 2019]). NBTY Inc. and Nature's Bounty Inc. make the vitamin E supplements in question. A consumer who purchased one bottle of the supplements for health reasons sued the manufacturers, claiming the labels' statements violated two California laws against false advertising because the supplements did not prevent cardiovascular disease (CVD) and might increase the risk of all-cause mortality. The district court granted summary judgment in favor of the manufacturers, and the plaintiff appealed to the Ninth Circuit. The Ninth Circuit affi rmed the district court's decision on the grounds that for dietary supplements, the Federal Food, Drug and Cosmetic Act (FD&C) distinguishes between "disease claims" and "structure/function claims" manufacturers make about their products. A structure/function claim "describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans" or "characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function," but "may not claim to diagnose, mitigate, treat, cure or prevent a specifi c disease or class of diseases." On the other hand, a disease claim "claims to diagnose, mitigate, treat, cure or prevent disease," either explicitly or implicitly. The court held that the FD&C preempted the plaintiff's claims regarding the manufacturers' assertions the supplements promoted and supported cardiovascular, circulatory and heart health to the extent that the plaintiff argued that the manufacturers' structure/function claims were false or misleading because their supplements did not prevent CVD. The court also decided the plaintiff's all-cause mortality claim had to fail. It observed that the plaintiff cited no evidence that vitamin E supplements caused an increased risk of all-cause mortality, as opposed to simply being useless at reducing all-cause mortality. In any event, the court pointed out the manufacturers did not claim that their supplements reduced all-cause mortality. In Atkins Nutritionals Case, Federal Court Permits Some Claims Over 'Net Carbs' Labeling to Move Forward A federal district court in New York ruled certain claims challenging "Net Carbs" labels on food products manufactured by Atkins Nutritionals Inc., could move forward while others had to be dismissed (Colella v. Atkins Nutritionals Inc., No. 17-cv-5867 [KAM] [E.D.N.Y. Dec. 7, 2018]). In the lawsuit, the plaintiff asserted that the following three "Net Carbs" labels on Atkins Nutritionals' food products were "false, misleading, and likely to deceive" consumers: the use of the phrase "Xg Net Carbs" while excluding sugar alcohols; the use of the phrase "Only Xg Net Carbs;" and Atkins Nutritionals "Counting Carbs" label, which explained the calculation method for Net Carbs and stated that sugar alcohols "minimally impact blood sugar." The plaintiff alleged the claims were likely to deceive consumers because Atkins Nutritionals claimed sugar alcohols "minimally" impacted blood sugar, but sugar alcohols had been proven to "have a signifi cant impact on blood sugar levels." Atkins Nutritionals moved to dismiss the lawsuit that the court granted and denied in part. In its decision, the court fi rst ruled the plaintiff's state law claims relating to Atkins Nutritionals' use of the phrase "Xg Net Carbs," and its explanation of the calculation method for Net Carbs that subtracted sugar alcohols and fi ber from total carbohydrates were preempted by the FD&C. The court reasoned that "Net Carbs" nutrient content claims were not prohibited under federal law, so they could not be challenged under state laws. The court, however, also determined that the plaintiff's claims regarding the "Only Xg Net Carbs" statement on labels—an implied nutrient content claim—were not preempted. The court explained that an implied nutrient content claim suggested to consumers that a nutrient was present in a certain amount. The court said the foods might be misbranded under the FD&C because Atkins Nutritionals used the term "only" on certain food labels without clarifying such foods were not "low carbohydrate." But the court's analysis may not have been entirely correct. While FDA has defi ned many nutrient content claims, FDA's regulations do not defi ne any terms to describe the amount of carbohydrate in food. Finally, the court ruled the plaintiff's claims relating to the portion of the "Counting Carbs" information box on the label were not preempted. According to the court, Atkins Nutritional's statement in its "Counting Carbs" information box regarding the impact of sugar alcohols on blood sugar levels was not a nutrient content claim. The court explained it was not "a quantitative statement about sugar alcohols" and it did not imply sugar alcohols were present in the labeled items in a certain amount. As such, the court concluded, it did not fall under the FDA regulation for nutrient content claims or other health related claims and was outside the law's preemption provision. Frank Misiti, partner at Rivkin Radler LLC (rivkinradler.com), is an experienced litigator representing clients in intellectual property, complex insurance c overage, commercial and other business disputes in state and federal courts throughout the country. Michael Cannata, partner at Rivkin Radler, is a seasoned litigator with extensive experience litigating complex, intellectual property, insurance coverage and other commercial disputes in federal and state courts throughout the country. Legal: Lawsuits

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